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N/A
15 Years
55 Years
Not Enrolling
Both
Painful Digital Neuroma

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Trial Information


Our selection criteria in this study included a patient with PDN in a scarred wound bed or
poor coverage, a PDN located between the middle of the distal phalanx and the palmar digital
crease, and a defect of the digital nerve after neuroma resection equal to or less than 3 cm
in length. The exclusion criteria included a PDN in healthy soft tissue, a digital nerve
defect longer than 3 cm, injury to the course of the pedicle or the donor nerve, and a thumb
neuroma. A finger with a small distal end of the digital nerve was also excluded, because
neurorrhaphy was extremely difficult in this situation.


Inclusion Criteria:



- a patient with PDN in a scarred wound bed or poor coverage

- a PDN located between the middle of the distal phalanx and the palmar digital crease

- a defect of the digital nerve after neuroma resection equal to or less than 3 cm in
length

Exclusion Criteria:

- a PDN in healthy soft tissue

- a digital nerve defect longer than 3 cm

- injury to the course of the pedicle or the donor nerve

- a thumb neuroma

Type of Study:

Interventional

Study Design:

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Outcome Measure:

static 2-point discrimination test

Outcome Description:

The test points were at the center of the radial or ulnar portion of the finger pulp (i.e., injury side) and the donor site separately. The modified American Society for Surgery of the Hand guidelines was used to stratify the 2PD measurements (excellent <6 mm; good 6-10 mm; fair 11-15 mm; poor >15 mm) [11].

Outcome Time Frame:

20-26 months postoperatively

Safety Issue:

No

Principal Investigator

Gang Zhao, MD.

Investigator Role:

Study Chair

Investigator Affiliation:

The Second Hospital of Tangshan

Authority:

United States: Food and Drug Administration

Study ID:

HB-TS-120127

NCT ID:

NCT01684839

Start Date:

May 2007

Completion Date:

March 2012

Related Keywords:

  • Painful Digital Neuroma
  • Painful digital neuroma
  • nerve defect
  • dorsal branch of the digital nerve
  • digital nerve
  • pedicled nerve flap
  • Pain Disorder Associated with Psychological and Physical Factors
  • Neuroma
  • Pain

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